RX Cholangiogram KitRecalls & reported problems across all models

We found 8 models of RX Cholangiogram Kit by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jan 21, 2020 and Jan 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

RX Cholangiogram Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0781-2022 · Root cause: Packaging process control · names 8 of these models · Recall details · FDA record ↗

2. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0780-2022 · Root cause: Packaging process control · names 8 of these models · Recall details · FDA record ↗

Most reported RX Cholangiogram Kit problems

RX Cholangiogram Kit models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RX Cholangiogram Kit M00575360

  Endoscopic Cholangiogram Kit
  2 recalls1 report
• RX Cholangiogram Kit M00575240

  Endoscopic Cholangiogram Kit
  2 recalls0 reports
• RX Cholangiogram Kit M00575280

  Endoscopic Cholangiogram Kit
  2 recalls0 reports
• RX Cholangiogram Kit M00575320

  Endoscopic Cholangiogram Kit
  2 recalls0 reports
• RX Cholangiogram Kit M00575380

  Endoscopic Cholangiogram Kit
  2 recalls0 reports
• RX Cholangiogram Kit M00575400

  Endoscopic Cholangiogram Kit
  2 recalls0 reports
• RX Cholangiogram Kit M00575440

  Endoscopic Cholangiogram Kit
  2 recalls0 reports
• RX Cholangiogram Kit M00575480

  Endoscopic Cholangiogram Kit
  2 recalls0 reports

Recent RX Cholangiogram Kit adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2020Break; Break

  IT WAS REPORTED THAT RX CHOLANGIOGRAM WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE FROM DISTAL END OF CATHETER. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610260 ↗

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